- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06754111
The Effect of Ideal Birth Environment on Birth Pain, Fear of Childbirth, Mode of Delivery and Duration of Delivery
The aim of this study was to investigate whether the ideal birth environment is related to fear of childbirth, labor pain, duration of labor, and mode of delivery.
on the impact of the study. The main questions it aims to answer are Does the ideal birth environment reduce fear of childbirth? Does the ideal birth environment reduce labor pain? does the ideal birth environment affect the duration of labor? In order to evaluate the effect of the ideal birth environment on fear, pain and duration of labor, the researchers will compare the standard delivery room and women who will give birth in a room customized for women, where they have their own sheets, pillows, items that make them feel special, where medical devices are reduced, in a room where they have photos with their partner, in a room where they listen to the music they want, where they have freedom of movement. both in the experimental and control groups: In the last trimester, the Wijma birth experience A version will be applied and in the postpartum period, the Wijma B Birth experience scale will be applied again and the fear of childbirth will be evaluated. Pain in labor will also be assessed using VAS (Visceral Visual Analgesic Scale) during the latent and active phase of labor.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The birth environment filled with medical instruments increases the level of anxiety and fear in the mother.
increase, disrupting the neurohormonal relationship that ensures the normal functioning of labor and an increase in the rate of cesarean section deliveries. Also women when she does not feel safe in her environment and her baby does not feel safe, the birth process is temporary. may slow down as a result release of adrenaline (epinephrine) and noradrenaline (norepinephrine) as a result of stress and anxiety increases, creating a "fight or flight" situation in the woman. Adrenaline and noradrenaline are the main
towards the end of labor to help the fetus to expel, while towards the end of labor should be at a low level at the beginning. The woman cannot fight stress in these cases, adrenaline and noradrenaline levels increase, while oxytocin levels decrease. This one from a physiological point of view, it can cause the progression of labor to stop, the duration prolonged labor and increased cesarean section rates. In a study conducted with pregnant rats, noise and movement in the birth environment restriction has been found to negatively affect hormones involved in labor
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bucak
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Burdur, Bucak, Turkey, 15300
- Mehmet Akif Ersoy Üniversitesi
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
18-35 years old pregnant primiparous literate
Exclusion Criteria:
Medium and high-risk pregnant women (oligohydramnios, pre-eclampsia, heart disease, diabetes, placenta previa)
- Psychiatric illness such as anxiety and depression
- Communication barrier
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
will receive standard care, no intervention will be performed
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|
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Active Comparator: ideal birth environment
ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow |
ideal birth room While designing a single room without unnecessary medical equipment, your own bed linen, bed linen, It will be a pillow case, a photo frame, he will be able to listen to the music he wants, he will be able to make a photo of his own choice. There will be a companion, a birthing ball and chair, and the room will allow freedom of movement. It will be designed to allow |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wijma Birth Expectancy/Expectation Questionnaire (W-DEQ) A Version
Time Frame: 28-36 weeks of gestation
|
Wijma Birth Expectancy/Expectation Scale A Version (W-DEQ A), W-DEQ consists of 33 items and is a six-point Likert-type scale. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high.
The alpha value of the scale is calculated by inverting the scale in the opposite direction. Cronbach's alpha value of the scale 0.89 (Korukcu et al., 2012) Wijma Birth Anticipation/Experience Sc |
28-36 weeks of gestation
|
|
VASA Pain Assessment Scale
Time Frame: during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
|
Quantitative pain rating scale (QPRS) is used to assess the severity of pain. is used.
On a numerical rating scale, pain ranges from 0 (no pain) to 10 (unbearable pain) score (Price et al., 1983).
|
during the latent phase of labor when the cervical opening is 1-3 cm and during the active phase of labor when the cervical opening is 5-7 cm
|
|
WIJMA BIRTH EXPECTANCY/EXPERIENCE SCALE B VERSION
Time Frame: up to the first 12 hours after birth
|
he W-DEQ consists of 33 items and is a six-point Likert-type questionnaire. Item responses are numbered from 0 to 5, with 0 indicating "completely" and 5 indicating "not at all". is expressed. The minimum score is 0 and the maximum score is 165. The cut-off value is 85 points and a score of 85 and above is expressed as clinical fear. is also analyzed. The higher the total score of the scale, the higher the degree of fear experienced. is high.
is calculated by inverting it in the opposite direction in order to provide Translated with www.DeepL.com/Translator (free version) |
up to the first 12 hours after birth
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GO 2024/510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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